May 17 - 4:59
Ireland medical device regulations are unified with other European Union countries and follow the same EU MDR and IVDR regulation. However, each country has their own Regulatory Authority (RA). In the case of Ireland,...
Apr 18 - 4:23
The US Medical Device regulating authority, the Food and Drug Administration (FDA), has issued a Safety Communication to warn all potential users on risks associated with the use of unapproved diagnostic medical...
Apr 12 - 5:57
Medical devices in Greece are regulated by The National Organization for Medicines (EOF), a public entity of the Ministry of Health. Greece, as a member of European Union, classifies medical devices according to their...
Apr 5 - 3:14
The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte), BfArM, is the institution responsible for regulating medical devices in Germany. Headquartered in Bonn, BfArM...
Jan 17 - 2:38
In Brazil, the institution that oversees medical device regulations is the Brazilian National Health Surveillance Agency (ANVISA). The beginning of the medical device registration process requires the classification of...
